Kornimate/medical-research-clean huggingface dataset:
therapeutic drug monitoring of tildrakizumab in psoriasis patients

Conditions: Psoriasis Vulgaris

Summary: biologics such as tildrakizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. but they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. in this study, the investigators aim to investigate the predictive value of early serum trough levels of tildrakizumab and determine the therapeutic window of tildrakizumab in psoriasis patients.

patients will be included after signing informed consent. after inclusion, patients will continue on standard dosing schedule of tildrakizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (100mg)). during each study visit blood will be taken in order to quantify ctroughs and/or anti-drug antibodies towards tildrakizumab. in addition, psoriasis area and severity index (pasi) and investigator's global assessment (iga) score will be evaluated by a physician. patients complete the dermatology life quality index (dlqi) and european quality of life eq-5d instrument at each visit.

Eligibility criteria:
inclusion criteria: * participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis * participants must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: * participants who have currently a predominant nonplaque form of psoriasis * participants who are pregnant, nursing or planning a pregnancy * participants who are unable or unwilling to undergo multiple venapunctures * participants who are treated according to a different dosing schedule than standard dosing of tildrakizumab

Keywords: therapeutic drug monitoring psoriasis tildrakizumab
parkinson's foundation pd generation genetic registry

Conditions: Parkinson's Disease

Summary: development of a central repository for pd-related genomic data for future research.

the purpose of this study is to develop a central repository for pd-related genomic data by individuals who consent to deposit their data and bank their residual dna obtained through clinical genetic testing for future research use.

Eligibility criteria:
inclusion criteria: * study population 1: pwp (open for recruitment) 1. meet movement disorder society (mds) clinical diagnostic criteria for parkinson's disease: probable diagnosis. 2. willingness to undergo genetic testing, and choose to be informed of genetic testing results for gba, lrrk2 and 5 additional pd related genes (snca, vps35, prkn, pink-1, park7). 3. capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (icfs) based on site clinician's determination. 4. able to perform study activities (including completion of either online, in-person or paper surveys). study population 2: people at risk of developing pd (not open for recruitment) 1. family members of study population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory. exclusion criteria: 1. diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus. 2. individuals who have received a blood transfusion within the past 3 months. 3. individuals who have active hematologic malignancies such as lymphoma or leukemia. 4. individuals who have had a bone marrow transplant within the past 5 years. 5. under the age of 18

Keywords: genetics genetic counseling whole genome sequencing
diflomotecan (bn80915) administered once every 3 weeks in treating patients with sensitive small cell lung cancer (sclc)

Conditions: Small Cell Lung Cancer

Summary: this is a phase ii, open-label, multicenter, single-arm, exploratory "proof of concept" study. diflomotecan (7 mg fixed dose) will be administered as a 20-minute iv infusion once every 3 weeks in patients with sensitive small cell lung cancer (sclc) with progressive disease after first-line treatment with a platinum-based regimen.


Eligibility criteria:
main inclusion criteria: * documented small cell lung cancer (sclc) * measurable disease * one line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months main exclusion criteria: * uncontrollable brain metastasis * treated with an investigational drug within 30 days
theta burst stimulation for compulsive behavior non-invasive brain stimulation study

Conditions: Compulsive Behavior; Obsessive-Compulsive Disorder

Summary: this project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region in two directions (up or down) and measure effects on compulsive behaviors and related measures. this work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.


Eligibility criteria:
inclusion criteria: participants will: 1. be between the ages of 18 and 55 years 2. endorse problematic compulsive behaviors, per self-report and clinician-administered measures. 3. agree to video taping of structured clinical interview 4. report that they will reside in the pittsburgh area for at least 5 weeks exclusion criteria: 1. failure to meet standard mri inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. dental fillings do not present a problem. plastic or removable dental appliances do not require exclusion. history of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. pregnancy, determined by pregnancy tests on females. 2. medical contraindications for transcranial magnetic stimulation (tms): 1. presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches) 2. recurrent seizures or epilepsy in participant or family history of hereditary epilepsy 3. pregnancy 4. metallic implants in body or other devices that may be affected by magnetic field 5. significant heart disease or cerebrovascular disease 6. medications with seizure threshold lowering potential, e.g., clomipramine, monoamine oxidase inhibitors (maoi's), imipramine, clozapine 3. acute suicidality or other psychiatric crises requiring treatment escalation 4. changes made to treatment regimen within 4 weeks of baseline assessment 5. reading level \<6th grade 6. presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current use of mood altering drugs such as cocaine, cannabis or marijuana, opiates, amphetamines, and barbiturates) 7. presence of movement disorder or tics affecting manual responses 8. inability to read text from 2 feet away (corrective lenses allowed)
a study to evaluate the safety and efficacy of tocilizumab in patients with severe covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (tcz) compared with a matching placebo in combination with standard of care (soc) in hospitalized patients with severe covid-19 pneumonia.


Eligibility criteria:
inclusion criteria: * hospitalized with covid-19 pneumonia confirmed per who criteria (including a positive pcr of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest x-ray or ct scan * spo2 \</=93% or pao2/fio2 \<300 mmhg exclusion criteria: * known severe allergic reactions to tcz or other monoclonal antibodies * active tuberculosis (tb) infection * suspected active bacterial, fungal, viral, or other infection (besides covid-19) * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * have received oral anti-rejection or immunomodulatory drugs (including tcz) with the past 3 months * participating in other drug clinical trials (participation in covid-19 anti-viral trials may be permitted if approved by medical monitor) * pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination * treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational covid-19 antivirals may be permitted if approved by medial monitor) * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 10 x upper limit of normal (uln) detected within 24 hours at screening (per local lab) * absolute neutrophil count (anc) \< 1000/ml at screening (per local lab) * platelet count \< 50,000/ml at screening (per local lab)
comparison of the leuven protocol with the glucommander for postoperative control of blood glucose with iv insulin

Conditions: Diabetes

Summary: the investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.

in 2002 we adapted the protocol described by van den berghe et al. for use in our own surgical intensive care unit (sicu) with a target blood glucose range from 80 to 120mg/dl. after five years of implementation, we were able to achieve a mean bg of 117 mg/dl in the sicu. 2% of glucose values were \<60 mg/dl in the sicu. given the concern of safety while optimizing glycemic control, we investigated the etiologies for these hypoglycemic episodes and have found two frequent risk factors; the failure to consistently measure blood glucose every hour and in patients with end stage renal failure. we will investigate whether a computer-based algorithm for the titration of iv insulin will translate to better clinical outcomes and less hypoglycemia. therefore, we will conduct a prospective randomized trial comparing the glucommander, a computer-based algorithm with our van den berghe protocol for titration of iv insulin in patients after cardiovascular or transplant surgery. this computer based algorithm was invented in 1984 in atlanta by dr. davidson and dr. steed who have used it in a variety of applications of iv insulin.

Eligibility criteria:
inclusion criteria: * s/p open heart or kidney or liver transplant surgery exclusion criteria: * admission blood glucose less than 120 mg/dl

Keywords: postoperative blood glucose control iv insulin infusion
biopsy of human tumors for cancer stem cell characterization: a feasibility study

Conditions: Head and Neck Cancer; Head and Neck Cancers

Summary: to see if a limited sampling of tumor tissue from human subjects is a feasible way to gather adequate tissue for cancer stem cell quantification.


Eligibility criteria:
inclusion criteria:1. patients with malignant tumors seen at the stanford university cancer center. eligible patients will have a diagnosis of squamous cell carcinoma (hnscc) and will have been seen in the stanford head and neck oncology program. a decision to undergo surgery at stanford will have been made, prior to recruiting patients for the study, and prior to obtaining the samples during surgery. (histological confirmation of the diagnosis need not be made prior to obtaining consent.) 2. a definitive resection of a malignant tumor is planned. 3. surgeon judgment that the definitive procedure will not be compromised by including * fna * core needle biopsy * cup forceps or punch biopsy of\<4mm. 4. informed consent documented prior to procedure
pulse width 0.15ms vs 0.30ms in electroconvulsive therapy

Conditions: Major Depressive Disorder; Bipolar Depression

Summary: the pwect015 study was designed to compare the application of 0.15ms and 0.30ms pulse width in electroconvulsive therapy (ect). subjects will be compared both within groups and in-group via psychometric scales.

this study is a controlled randomized clinical trial. patients (projected n=40 are randomized into two groups - blue (20) and red (20). randomization will be blocked (size sample 4) - 1 allocator. ect practitioners are aware which patient belongs to which group but are blinded to block size. testers are blinded to what group the patients belong to and what ect parameters are used. patients and attending psychiatrists are also blinded as to which group the patient belongs to. the mecta sigma device will be used for ect. cross-over titration by stimulation will be used during the application of ect to find the seizure threshold (st) as follows: red group 1. session - titration with 0.15ms 2. session - titration with 0.3 ms 3. session and further - continue with 0.3 ms pulse width and 6x st found during the second session. blue group 1. session - titration with 0.30ms 2. session - titration with 0.15ms 3. session and further - continue with 0.15ms pulse width and 6x st found during the second session. delivered energy is measured in percentage (%) of the maximum charge (in millicoulombs, mc) that the european version of the mecta sigma device is able to administer. total amount of ect applications is individual and based on the clinical state of the patient. ect outcome will be predicted via seizure duration (sd). if the seizure duration is less than 15s, the ect dosage will be increased during next session by 100%. throughout the ect course, patients will be closely monitored by the testers via psychometric scales. primary outcome of the study is measured via time to recovery (ttr) - which is measured after each ect application. ttr is the time (in minutes) after which the patient is fully vigilant and aware of his surroundings after an ect procedure. ttr will be compared both in-group and between groups. other psychometric measures are specified in the outcome measures section.

Eligibility criteria:
inclusion criteria: * age equal to 18 or higher * score equal or higher than 20 on the montgomery-asberg depression scale (madrs), * major depressive disorder or bipolar depression exclusion criteria: * other axis 1 disorder * ect in the last 3 months * neurological disease * psychosis * pregnancy * any somatic condition that contraindicates ect

Keywords: electroconvulsive therapy, depression, pulse-width
analysis of donor milk

Conditions: Breast Milk Collection; Nutrition Disorder, Infant

Summary: the purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in north america

aim 1: to measure the micronutrient, macronutrients, microbial count, and endotoxins present in donated human breastmilk purchased from commercial human milk banks in north america (table 2). aim 2: to compare the results of the nutrient analysis to nutrient recommendations for premature infants. (table 3). aim 3: to use the results of the nutrient analysis to calculate the final nutrient content of donor human milk after the addition of commonly used human milk fortifiers (hmf). we will compare the calculated nutrients with intake recommendations for premature infants. background preterm infants are at risk for nutrition depletion because of inadequate placental transfer, low volume feedings in the first days of life, and increased nutrient needs.1-3 adequate intake of nutrients during neonatal development is crucial for growth. in addition, preterm infants are vulnerable to feeding-related complications, including necrotizing enterocolitis (nec) and enteral feeding intolerance.4,5 human milk feedings reduce the risk of nec and enteral feeding intolerance and are considered the standard of feeding for this population. when mother's own milk (mom) is not available or is inadequate to meet the needs of the infant, donor human milk (dhm) is the recommended feeding choice for preterm infants with birth weights ≤1500 grams.5 several factors influence the nutrient composition of human milk, including lactation stage, gestational age at delivery, maternal age, body mass index (bmi), diet, and race.6-8 preterm mom is more nutrient-dense than mature human milk and continues to change as the lactation stage progresses.6,7,9 donors of human milk are typically mothers of infants born at term and are unlikely to donate milk in the first month after delivery when milk is most nutrient-dense. in 2011 22% of american neonatal intensive care units (nicu) used dhm to feed preterm infants. by 2017 the number of nicu purchasing dhm increased to 75%.10 to meet the demand for dhm, the number of human milk banks has increased from two in 1985 to more than thirty in 2020. the human milk banking industry is self-regulated with little oversight from governmental agencies. donor human milk can be purchased from non-for-profit, private, public-benefits companies, or mother's milk co-operatives. practices for donor selection, milk pooling, pasteurization or sterilization, nutrient analysis, and labeling vary by bank.11 most dhm banks in north america do not report the nutrient composition of the dhm they sell. of those that do, only three report nutrients other than protein, energy, and fat. understanding the nutrient profiles of dhm is essential for creating feeding plans to meet the needs of preterm infants.

Eligibility criteria:
inclusion criteria: * donor human milk from commercially available milk banks exclusion criteria: -
icotinib in advanced non-small cell lung cancer (nsclc) with hepatic insufficiency

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine whether icotinib is efficient and safe in treating advanced non-small cell lung cancer (nsclc) patients with hepatic insufficiency.

patients with hepatic insufficiency is an important subgroup of who receive egfr tkis. phase i/ii studies showed that icotinib has good security. based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed nsclc patients with hepatic insufficiency.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of iiib/iv stage nsclc patients who are not suitable for surgery or radiotherapy * ecog performance status points (ps) is 0-2 * liver function: a (mild hepatic dysfunction): a1) total bilirubin within normal limit (uln), while ast\> uln; a2) total bilirubin within1.0-1 .5 × uln; b (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × uln * no malabsorption or other gastrointestinal disorders effecting drug absorption * life expectancy: more than 12 weeks. exclusion criteria: * previous usage of her/egfr inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy ) * patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process . * patients with active hepatitis and cirrhosis.
single-dose, crossover study to compare bioavailability of two formulations under fed and fasted conditions

Conditions: Healthy

Summary: to compare the bioavailability of 40 mg doses of pf-00345439 modified formulation k vs. original formulation x under fed and fasting conditions in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between 18 and 55 years of age exclusion criteria: * evidence or history of clinically significant disease. * positive urine drug test

Keywords: pharmacokinetics bioequivalence bioavailability oxycodone
patient centered outcomes in rosacea: an exploratory multi-media analysis of the patient experience on oracea

Conditions: Papulopustular Rosacea

Summary: the purpose of this study is to characterize rosacea patients', being treated with oracea, perception through visual analog scale reporting.


Eligibility criteria:
inclusion criteria: * men and women * 25-70 years * diagnosis of papulopustular rosacea * eligible for oracea treatment exclusion criteria: * allergies to components of investigational product and/or hypersensitivity to tetracyclines * taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit * used topical rosacea treatment within 30 days prior to baseline visit * have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist * previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics * exposed to intense/excessive ultraviolet (uv) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive uv exposure during the course of the study * have planned surgical procedures during the course of the study * have used tetracycline antibiotics within 30 days prior to baseline visit or during study * at risk in terms of precautions, warnings, and contraindications

Keywords: papulopustular rosacea oracea anti inflammatory doxycycline
fixed order, open-label, dose-escalation study of dmt in humans

Conditions: Major Depressive Disorder; Depression

Summary: the goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (dmt) in humans.

the results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. the investigators hypothesize that the administration of dmt will result in neuroplastic changes in healthy and depressed subjects. these changes in neuroplasticity will be indexed using electroencephalographic (eeg) measures and tasks. these neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Eligibility criteria:
healthy controls inclusion criteria: * medically healthy * psychiatrically healthy healthy controls exclusion criteria: * unstable medical conditions * psychiatric illness depression inclusion criteria: * medically healthy * diagnosis of major depressive disorder depression exclusion criteria: -unstable medical conditions